Person who experienced the adverse event (patient)
| Event ID | CASEID | CASEVERSION | I F COD | EVENT DT | MFR DT | INIT FDA DT | FDA DT | REPT COD | AUTH NUM | MFR NUM | MFR SNDR | LIT REF | AGE | AGE COD | AGE GRP | GNDR COD | E SUB | WT | WT COD | REPT DT | TO MFR | OCCP COD | REPORTER COUNTRY | OCCR COUNTRY |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126475733 | 12647573 | 3 | F | 20110906 | 20160822 | 20160812 | 20160906 | EXP | US-SUN PHARMACEUTICAL INDUSTRIES LTD-2016US-122123 | RANBAXY | 46.00 | YR | M | Y | 0.00000 | 20160906 | OT | GB | US |
Drug(s) used by person
| Event ID | CASEID | DRUG SEQ | ROLE COD | DRUGNAME | PROD AI | VAL VBM | ROUTE | DOSE VBM | CUM DOSE CHR | CUM DOSE UNIT | DECHAL | RECHAL | LOT NUM | EXP DT | NDA NUM | DOSE AMT | DOSE UNIT | DOSE FORM | DOSE FREQ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126475733 | 12647573 | 1 | PS | FLECAINIDE ACETATE. | FLECAINIDE ACETATE | 1 | Unknown | 50 MG, BID | Y | U | 76421 | 50 | MG | Q12H |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126475733 | 12647573 | 1 | Ventricular extrasystoles |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126475733 | 12647573 | OT |
| 126475733 | 12647573 | LT |
| 126475733 | 12647573 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126475733 | 12647573 | Acute kidney injury | |
| 126475733 | 12647573 | Bundle branch block right | |
| 126475733 | 12647573 | Hypotension | |
| 126475733 | 12647573 | Mental status changes | |
| 126475733 | 12647573 | Overdose | |
| 126475733 | 12647573 | Tachycardia | |
| 126475733 | 12647573 | Toxicity to various agents |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |